510(k) K843506
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 1984
- Date Received
- September 6, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Processor, Tissue, Automated
- Device Class
- Class I
- Regulation Number
- 864.3875
- Review Panel
- PA
- Submission Type